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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, Garofolo F, Haidar S, Islam R, James C, Kadavil J, Kavetska O, Li F, Satterwhite C, Savoie N, Subramaniam S, Tampal N, Thway T, Woolf E, Blaye OL, Andisik M, Briscoe C, Cape S, Dasgupta A, Fischer S, Haidar S, Hayes R, Kamerud J, Lima Santos GM, Nehls C, Soo C, Vinter S, Whale E, Xu K, Cho SJ, Edmison A, Kassim S, Rocha TC, Welink J, Amur S, Bandukwala A, Cherry E, Hopper S, Ishii-Watabe A, Kirshner S, Maher K, Pedras-Vasconcelos J, Saito Y, Saunders TS, Skibeli V, Verthelyi D, Wang YM, Yan H. Booth B, et al. Among authors: subramaniam s. Bioanalysis. 2019 Dec;11(23):2099-2132. doi: 10.4155/bio-2019-0270. Epub 2019 Dec 9. Bioanalysis. 2019. PMID: 31833782 Free article.
Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.
Booth B, Arnold ME, DeSilva B, Amaravadi L, Dudal S, Fluhler E, Gorovits B, Haidar SH, Kadavil J, Lowes S, Nicholson R, Rock M, Skelly M, Stevenson L, Subramaniam S, Weiner R, Woolf E. Booth B, et al. Among authors: subramaniam s. AAPS J. 2015 Mar;17(2):277-88. doi: 10.1208/s12248-014-9696-2. Epub 2014 Dec 31. AAPS J. 2015. PMID: 25549614 Free PMC article.
Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response.
Li H, Yu J, Liu C, Liu J, Subramaniam S, Zhao H, Blumenthal GM, Turner DC, Li C, Ahamadi M, de Greef R, Chatterjee M, Kondic AG, Stone JA, Booth BP, Keegan P, Rahman A, Wang Y. Li H, et al. Among authors: subramaniam s. J Pharmacokinet Pharmacodyn. 2017 Oct;44(5):403-414. doi: 10.1007/s10928-017-9528-y. Epub 2017 Jun 1. J Pharmacokinet Pharmacodyn. 2017. PMID: 28573468
FDA Approval Summary: Glasdegib for Newly Diagnosed Acute Myeloid Leukemia.
Norsworthy KJ, By K, Subramaniam S, Zhuang L, Del Valle PL, Przepiorka D, Shen YL, Sheth CM, Liu C, Leong R, Goldberg KB, Farrell AT, Pazdur R. Norsworthy KJ, et al. Among authors: subramaniam s. Clin Cancer Res. 2019 Oct 15;25(20):6021-6025. doi: 10.1158/1078-0432.CCR-19-0365. Epub 2019 May 7. Clin Cancer Res. 2019. PMID: 31064779 Clinical Trial.
FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen.
Barone A, Chi DC, Theoret MR, Chen H, He K, Kufrin D, Helms WS, Subramaniam S, Zhao H, Patel A, Goldberg KB, Keegan P, Pazdur R. Barone A, et al. Among authors: subramaniam s. Clin Cancer Res. 2017 Dec 15;23(24):7448-7453. doi: 10.1158/1078-0432.CCR-17-0898. Epub 2017 Aug 3. Clin Cancer Res. 2017. PMID: 28774898 Clinical Trial.
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.
Pai-Scherf L, Blumenthal GM, Li H, Subramaniam S, Mishra-Kalyani PS, He K, Zhao H, Yu J, Paciga M, Goldberg KB, McKee AE, Keegan P, Pazdur R. Pai-Scherf L, et al. Among authors: subramaniam s. Oncologist. 2017 Nov;22(11):1392-1399. doi: 10.1634/theoncologist.2017-0078. Epub 2017 Aug 23. Oncologist. 2017. PMID: 28835513 Free PMC article. Clinical Trial.
1,510 results